Sisters Peer Counseling in Reproductive Issues After Treatment (SPIRIT)

A peer counseling program to improve reproductive health among African American breast cancer survivors

Authors


Abstract

BACKGROUND:

African American breast cancer survivors may be at high risk for reproductive health problems, including menopause symptoms, sexual dysfunction, and distress about cancer-related infertility. The authors partnered with Sisters Network Inc. to create the Sisters Peer Counseling in Reproductive Issues After Treatment (SPIRIT) program, a culturally sensitive intervention program that combined a written workbook and peer counseling.

METHODS:

Three hundred women were randomized to receive either the workbook plus 3 in-person sessions with a trained peer counselor or the workbook plus ≤30 minutes of telephone counseling to be initiated by the participant. Questionnaires at baseline, post-treatment, and at 6-month and 12-month follow-up assessed emotional distress, sexual function, relationship satisfaction, spirituality, menopause symptoms, and knowledge. Satisfaction with the program and the use of medical care also were assessed.

RESULTS:

Both groups of women improved significantly in knowledge, decreased in distress, and had decreased hot flashes. Sexually active women had improved sexual function at 6-month follow-up but not at 1 year. However, peer counseling had little incremental benefit over the telephone counseling.

CONCLUSIONS:

The SPIRIT program was rated very useful by 66% of women. Outcomes justify continued use of the workbook and further research to optimize the impact of peer counseling. Cancer 2011;. © 2011 American Cancer Society.

Survivors of breast cancer rate their overall quality of life positively,1-3 yet problems with reproductive health remain long-term concerns for as many as half of women.1, 2, 4-7 Psychological distress diminishes over the first year after breast cancer diagnosis, but sexual dysfunction, menopausal symptoms, and infertility-related distress remain severe and pervasive.1-7 Premenopausal women who experience abrupt, treatment-related, premature ovarian failure have the greatest risk of developing such symptoms,4, 8, 9 but women who are treated with aromatase inhibitors also experience severe sexual and menopausal complaints.10

African American women may be particularly vulnerable to reproductive health problems after breast cancer. Compared with Caucasian women, African American women are less likely to be diagnosed at an early stage,11 have higher mortality rates,12 and are more likely to be diagnosed before age 40 years.11 African American breast cancer survivors aged >50 years report poorer physical quality of life than white survivors.13, 14

Although sexuality is not always discussed openly in the African American community, it is salient for African American women. In fact, African American women who were unselected for health rated sex as more important than Caucasian women and reported higher rates of sexual activity.15, 16 They also reported more frequent and distressing hot flashes17, 18 and more severe vaginal dryness17, 19 than Caucasian women. African American women have higher rates of infertility than white or Hispanic women, are less likely to seek medical help, and have poorer success rates if they use assisted reproductive technology.17

In a pilot study, we partnered with the national advocacy organization Sisters Network Inc. to create a pilot intervention, Sisters Peer Counseling in Reproductive Issues After Treatment (SPIRIT), which was designed to improve knowledge and reduce symptoms related to sexual dysfunction, menopause, and distress about infertility in African American breast cancer survivors.20 Forty-eight women were randomized either to begin counseling with 1 of 3 trained peer counselors or to enter a 3-month waitlist control group followed by the intervention. The program included a written workbook with detailed information on menopause, sexual function, and issues of pregnancy and fertility. Peer counseling was accomplished in 3 sessions, each of which focused on 1 of the chapters from the workbook. Because no significant changes in outcome measures occurred during the waitlist period, the groups were combined in analyzing the efficacy of the intervention. At 3-month follow-up, women's knowledge about reproductive health improved significantly. Hot flashes and emotional distress decreased. Although sexual function did not change significantly, emotional distress improved over time in women who were sexually dysfunctional at baseline. Eighty-one percent of women rated the program as “very useful to me.”

Given these positive results, we began a national trial of the SPIRIT program, again in partnership with Sisters Network Inc. The objectives of this study were 1) to assess the effectiveness of the full peer counseling program compared with a brief telephone counseling condition, both of which included the workbook; and 2) to examine the influence of medical, demographic, and psychosocial factors on baseline levels of reproductive problems and on the outcome of the intervention.

MATERIALS AND METHODS

This study was approved by The University of Texas MD Anderson Cancer Center Institutional Review Board (IRB).

Recruitment

Participants needed to self-identify as African American and to be at least 1 year postdiagnosis of breast cancer, off active treatment other than hormone therapy, and have adequate English skills. Recruitment sources included Sisters Network Inc. chapters, community events, health fairs, and church support groups. IRB-approved flyers were supplied to local beauty shops, car washes, mastectomy prosthesis and lingerie stores, etc. Peer counselors identified potential participants.

Screening, informed consent, and assessment procedures were conducted by research staff in Houston. Counselors were responsible only for the intervention. A team member elicited verbal consent for telephone screening for study eligibility. Women subsequently were mailed a written informed consent form along with the baseline questionnaires. If the forms were not completed and returned within 3 weeks, then the Houston team made up to 3 reminder calls and then sent 1 reminder letter before stopping further contact.

Study Design

Participants were assigned to 1 of the 2 treatment groups using minimization, which is a form of adaptive randomization.21 Before a participant was assigned to a group, the number of participants in each group with similar covariate characteristics were totaled based on marginal sums. Each covariate was considered separately. Assignment to treatment was based on maintaining the best overall balance. Variables used were age (<45 years vs ≥45 years), marital status (married vs not married), menopausal status at diagnosis, and current menopausal status.

Participants received a welcome letter with instructions on proceeding, a signed copy of the informed consent form, and the SPIRIT workbook. For the peer counseled group, a counselor was assigned to meet with the participant 3 times during the 6-week treatment period either in the participant's home or at a site like a church or community center. Each 60-minute to 90-minute session focused on 1 chapter of the workbook. Counselors sometimes traveled overnight to accommodate participants who lived in remote areas, conducting 3 sessions within a period of 1 or 2 days.

The telephone counseling group's packet included the workbook, the counselor's contact information, encouragement to call the counselor for up to 30 minutes to discuss issues in the SPIRIT workbook, and a prepaid telephone card. The counselor kept a log of the date, time, duration, and topic of any calls from the participant. The counselor did not initiate any contacts in the telephone condition unless the Houston team identified a need; for example, a questionnaire result might trigger a telephone assessment of psychological distress.

The SPIRIT Workbook

A 77-page workbook using African American themed clipart was revised using the pilot study results.20 The reading level was eighth grade (readability score, 61.2). Each chapter began with a list of topics (for example, “Learning more about ways to overcome vaginal dryness”). The survivor rated the personal importance of each topic before each counseling session, which helped to tailor the focus according to factors like patient age, concerns about sexuality or childbearing, etc. Breast cancer and menopause were discussed and strategies were suggested for decreasing hot flashes, vaginal dryness, and urinary incontinence. The sexuality chapter explained the impact of breast cancer treatments on pain with sex and loss of desire. Chapter 3, “Cancer and Your Family,” discussed inherited breast cancer, health of offspring, and becoming an advocate of cancer screening, issues important to women of all ages. For younger women, information was presented on infertility and pregnancy. Each chapter included an index of problems addressed with a summary of proposed solutions (self-help and medical).

Counselor Selection and Training

Forty-one peer counselors (African American breast cancer survivors) were trained, but only 27 counseled at least 1 participant. The original peer counselors 35 were chosen by Karen Jackson, founder and National President of Sisters Network Inc. Their expenses were paid to attend a 5-day counselor training conference at The University of Texas MD Anderson Cancer Center in November 2003. The curriculum included didactic material and experiential learning in supervised role plays. Each counselor received detailed treatment manuals for the peer counseling sessions and the telephone counseling condition.

Fourteen women dropped out of the counselor group, including 4 just after the training. Common reasons included poor health or life stress. Discomfort with the sexual topics was a factor for a few. During the course of the study, 5 counselors who were not fulfilling their responsibilities were dropped. Another 8 women were trained as counselors through intensive meetings with an experienced and successful counselor. New counselors passed a telephone evaluation by a Houston team member that included role plays using standardized scenarios.

By using a template, each counselor developed a local and national reproductive health resource list to give to participants. Counselors were compensated $40 per session for peer counseling and $30 per telephone case (which might involve 0 to 30 minutes of telephone time plus keeping a log of calls). Counselors who contributed more than 15 cases per year received a $10 raise for each additional peer counseling session or telephone counseling case as an incentive to recruit participants.

Quality Assurance: Regional Managers and the Houston Research Team

Seven counselors were appointed as regional managers. Managers acted as counselors but received additional compensation for weekly quality-control duties, which included checking by telephone with assigned counselors on recruitment efforts and counseling sessions and reviewing mental health or medical concerns. Counselors notified their manager of any urgent mental health issues. Managers consulted in turn with the Houston team. Counselors also could contact the Houston team directly for advice.

Houston team members included the principal investigator (L.R.S.), the project coordinator (P.L.), and postdoctoral fellows. Two counselors from the pilot study became research assistants. All were African American women other than Dr. Schover and 1 fellow. Monthly teleconference calls included regional managers and members of the Houston team. Common topics included recruitment strategies, reaching out into underserved and rural communities, and problems with participants or counselors.

Demographic and Medical Information

Demographic information obtained during the telephone screening included age, marital status, education, occupation, income, and ethnic identity. Women also reported years since breast cancer diagnosis, menstrual status at diagnosis and currently, and major categories of breast cancer treatment (see Table 1).

Table 1. Demographic and Medical Characteristics of Participants by Intervention Group
 Percentage of Participations 
VariablePeer Counseled, N=151Telephone Counseled, N=146P
  1. Abbreviations: NS, nonsignificant; SD, standard deviation.

Age: Mean±SD, y54.4±9.754.0±9.8NS
Time since diagnosis: Mean±SD, y7.0±7.06.0±5.4NS
Marital status   
 Married3940NS
 Divorced/separated3238 
 Widowed126 
 Never married1716 
Education   
 <High school46NS
 High school1313 
 Some college4142 
 Four-year college degree2119 
 Postgraduate degree1920 
 Missing20 
Family income   
 <$25,0002521NS
 $26,000-$50,0002840 
 $51,000-$75,0001923 
 $76,000-$100,000116 
 >$100,00076 
 Missing104 
Menstrual status   
 Regular cycles87NS
 Irregular cycles510 
 Postmenopausal4444 
 Hysterectomy4035 
 Missing34 
Breast surgery   
 Lumpectomy (unilateral)3539NS
 Mastectomy (unilateral)4444 
 Mastectomy (bilateral)78 
 Combination138 
 Missing11 
Breast radiotherapy5951NS
Chemotherapy7168NS
Sexually active at all assessment points5041NS

Outcome Measures

Participants filled out questionnaires at baseline, after the 6-week treatment period, and at 6-month and 1-year follow-up. At each follow-up, women were compensated $20 for their time and trouble. Packets were mailed by the Houston team at the designated time interval. If they were not returned within 3 weeks, then participants received up to 3 reminder calls and a letter.

Questionnaires included the 12-item Spiritual Well Being Subscale of the Functional Assessment of Cancer (FACIT-Sp),22 because spirituality has been identified as a particularly important factor in coping with cancer for African American women.23 Women who were married or in a serious relationship for ≥6 months completed an abbreviated 7-item form24 of the widely used Dyadic Adjustment Scale (A-DAS).25 Participants who were not in a serious relationship, instead, completed the 5-item Dating Subscale of the Cancer Rehabilitation Evaluation System (CARES),26 which measures comfort in dating after cancer.

To measure emotional distress, women completed the Brief Symptom Inventory-18 (BSI-18), an 18-item form of the BSI that includes items from the subscales that measure somatization, depression, and anxiety, as well as a Global Severity Index (GSI) summary score.27 Norms are based on 741 oncology patients, including 298 women with breast cancer.

The 19-item Female Sexual Function Index (FSFI) assessed 5 domains: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. A total FSFI score <26.55 indicated sexual dysfunction.28

To evaluate menopausal symptoms, we included 7 items from the Breast Cancer Prevention Trial Symptom Checklist.29 Respondents rated each symptom on a 5-point scale from not at all to extremely bothersome over the past 4 weeks. The items yield 3 subscales, including urinary incontinence, vaginal irritation, and hot flashes, and a summary score.30

We included 6 multiple-choice items from our previous surveys on having children after cancer.7, 31 Women rated their interest in having a child at the time of cancer diagnosis and concerns about becoming infertile after treatment, pregnancy triggering a cancer recurrence, cancer treatment damaging the health of subsequent children, and the lifetime cancer risk of offspring. One item asked whether experiencing cancer influenced desire to have children. Responses were added to create a composite score with a possible range from 6 to 25.

We created a 25-item true/false knowledge test for the SPIRIT pilot study, basing items on material in the workbook.20 For the national study, we replaced several items that were too easy with more difficult questions.

Use of Reproductive Health Care

At baseline, women were asked whether they had used 8 types of health care within the past year: a routine pelvic examination with Papanicolaou smear, help for a menopause-related problem, tests or treatment related to fertility, visit with an obstetrician about the safety of pregnancy, medical visit for a sexual problem, mental health visit for a sexual problem, and mental health visit for a problem unrelated to sex. These types of health care were discussed in the SPRIT workbook as potentially useful to some breast cancer survivors. At subsequent assessments, women were asked whether they had used each type of health care since joining the SPIRIT program.

Program Evaluation

At the post-treatment assessment, each participant was mailed a program evaluation questionnaire with a return envelope so that it could be sent anonymously, separate from other questionnaires. Many participants knew their counselors well and, if their questionnaire was identifiable, could be reluctant to give negative feedback. Women were asked to write the name of their counselor on the form, because ratings were used to check counselor performance.

Statistical Analyses

Descriptive analyses were conducted on questionnaire data from baseline and follow-up assessments (post-treatment and at 6 months and 12 months). Descriptive statistics (eg, frequencies, mean, range, standard deviation, skewness, and kurtosis), together with 95% confidence intervals (CIs), were obtained where appropriate. A 2-tailed probability of .05 was considered significant. Distributional characteristics of the variables were examined using box plots, histograms, quantile-quantile plots, and the Kolmogorov-Smirnov test of normality as appropriate. Knowledge scores, the prevalence of sexual dysfunction, menopausal symptoms, emotional distress, concern regarding childbearing, and medical service use were established with proportions of participants along with 95% CIs.

If differences between treatment groups did not approach significance at baseline or across time, then mixed-model analyses were calculated using all women in the sample. Each woman's change from baseline to subsequent follow-up points on an outcome measure was assessed to control for participant attrition across time. For all mixed models, a random intercept was used for the outcome measure with a repeated statement for the variable of time. An autoregressive correlation matrix was used. In addition, for the FSFI, models were calculated separately for the sample as a whole and only for women who were sexually active at all assessment time points.

RESULTS

Demographic and Medical Factors

Table 1 presents demographic and medical factors by intervention group for the women who participated in the study. Only 2 participants identified themselves as Latinas. Minimization was successful in ensuring that the 2 groups did not differ significantly.

Attrition Across Time

Table 2 presents the number of women who completed questionnaires at each assessment time point. Attrition across time did not differ significantly between the intervention groups. Fifteen women (13% of missing participants) stopped participation because of death or cancer recurrence.

Table 2. Questionnaire Completion Across Time
 No. of Patients (%)
Assessment PointPeer CounselingTelephone Counseling
Baseline152 (100)148 (100)
Postcounseling111 (73)104 (70)
At 6-mo follow-up94 (62)97 (66)
At 1-y follow-up89 (59)96 (65)

Psychosocial Outcome Variables

Table 3 presents questionnaire scores across time for the entire sample. Between-group comparisons did not differ significantly across time. In a mixed model (n = 291 participants at baseline and n = 184 participants at 12-month follow-up), a significant decrease in distress occurred across time, and a slight increase was observed again at 12-month follow-up (F[3, 293] = 4.97; P = .0022). Mean scores for the somatization subscale decreased significantly across time (P = .0002). There was a trend for depression to decrease (P = .0699). Initial mean GSI scores were elevated by only 0.5 standard deviations compared with the oncology norms and were close to the normative mean at follow-up. The percentage of women who met criteria for “caseness” on the BSI-18, ie, distress according to screening criteria, did not differ significantly between the intervention groups at any time point. The prevalence of “caseness” decreased over time, but not significantly (16.1% at baseline, 11.2% post-treatment, and 10.6% and 10.9%, respectively, at 6-month and 12-month follow-up).

Table 3. Outcomes Across Time for the Entire Sample
 Mean±SD Score 
VariableBaselinePost-Treatment6 Months12 MonthsP
  1. Abbreviations: A-DAS, abbreviated Dyadic Adjustment Scale; BSI-18, 18-item Brief System Inventory; FACIT-Sp, Functional Assessment of Chronic Illness Therapy-Spiritual Well Being Subscale; FSFI, Female Sexual Function Index; GSI, Global Severity Index; NS, nonsignificant; SD, standard deviation.

Knowledge16.4±2.817.8±3.517.5±3.518.1±3.3<.0001
BSI-18 GSI11.2±12.39.3±11.59.1±10.69.6±11.1<.0022
FSFI total18.2±10.718.1± 10.718.5±10.817.3±10.7NS
Total menopause symptoms2.7±1.72.7±1.82.7±1.82.8±1.7NS
Hot flashes1.8±1.41.7±1.41.6±1.41.7±1.3.0063
A-DAS21.0±6.521.5±7.021.0±7.220.9±7.2NS
Childbearing distress15.6±3.115.3±2.615.5±2.615.4±3.1NS
FACIT-Sp42.0±6.440.8±6.641.8±42.2±6.4NS

An interaction effect between treatment group and time was significant for depression scores (P = .0362, see Fig. 1). Depression decreased after treatment in the peer counseled group but temporarily increased in the telephone counseled group. By 12-month follow-up, scores in the 2 groups were very similar.

Figure 1.

Mean Brief Symptom Inventory Depression Subscale raw scores (time × treatment group) are illustrated. FU indicates follow-up.

No significant change was observed across time in the FSFI total score or subscale scores. However, when only the 115 women who were sexually active at all assessment points were included, total FSFI scores improved significantly from baseline to 6-month follow-up, but they decreased by 12-month follow-up (F[3, 185] = 2.47; P = .0630). Mean scores at all points remained in the dysfunctional range.30

Only 15% of our sample was still menstruating. On the menopausal symptom scale, hot flashes decreased significantly across time in both intervention groups (F[3, 572] = 4.15; P = .0063), including 293 women at baseline and 180 women at 12-month follow-up. Urinary symptoms and vaginal dryness did not change significantly across time, nor did the total symptom score. Scores on the A-DAS and on the CARES dating subscale did not differ significantly by group or across time.

Distress about childbearing issues was measured across time for 135 women who completed at least 6 of the 7 items. No significant changes were observed. At diagnosis, 20 women (7%) definitely wanted to have a child in the future, 9 women (3%) probably wanted a child in the future, and 15 women (5%) were unsure. The mean baseline childbearing distress score for this group of women (n = 42; 2 women were missing data) was 18.7 ± 4.6 (significantly greater; P < .0001) than the mean for other participants (n = 200; mean, 14.8 ± 2.0). Within this subgroup, distress decreased by 12-month follow-up (n = 26; mean, 17.7 ± 4.1), but the difference across time was not significant (P = .2340).

The 2 intervention groups did not differ significantly on knowledge test scores at baseline or across time. Although the Cronbach alpha of .53 for this sample was less than optimal, knowledge about reproductive health increased significantly over time (F[3, 579] = 22.48; P < .0001).

Factors Correlated with Knowledge and Sexual Function/Satisfaction at Baseline

Knowledge scores were significantly higher for women with 4-year college degrees (t[286] = 2.17; P = .0305) and higher incomes (t[270] = −1.89; P = .0592). Women with higher knowledge scores also had higher FSFI total scores (Pearson correlation coefficient [R2] = 0.20; P = .0038).

Married women (n = 103) had significantly better FSFI total scores than unmarried women (n = 119; 20.2 ± 10.0 vs 16.5 ± 11.1, respectively; t[220] = −2.56; P = .0112). Total FSFI scores were highly correlated with A-DAS scores for women in committed relationships (n = 127; Pearson R2 = 0.49; P < .0001). FACIT-Sp scores were correlated significantly with FSFI total scores (Pearson R2 = 0.15; P = .0213), particularly among women in committed relationships (Pearson R2 = 0.31; P = .0002).

Use of Reproductive Health Care

Health care use did not differ between intervention groups. Table 4 compares 175 women who had both baseline and 1-year data on rates of use during the previous year. Little change was evident in any single type of health care. Women used fewer types of health care at 1-year follow-up compared with baseline (F[3, 573] = 33.75; Pr > F < 0.00010). However, some women reported having a new type of health care at 12-month follow-up.

Table 4. Percentage of Women Using Health Care in the Past Year (N=175)
 Percentage of Women
Type of Health CareBaseline (in Past Year)12 Months (Since Study Began)Used at 12-Month Follow-Up but Not at Baseline
  1. Abbreviations: Pap, Papanicolaou; SD, standard deviation.

Saw family physician or gynecologist for routine pelvic examination and Pap smear87868
Saw family physician or gynecologist for menopause-related problem (ie, hot flashes, vaginal pain or dryness, trouble controlling urination, irregular cycles)333012
Had tests or treatment related to fertility (being able to get pregnant)211
Saw an obstetrician to discuss safety and health in pregnancy421
Saw a family physician or gynecologist for a sexual problem686
Saw a mental health counselor for a sexual problem222
Had genetic counseling and/or testing to see if inherited breast cancer was in my family1075
Saw a mental health counselor for a nonsexual problem897
No. of types of health care used, mean±SD   
 Peer group1.48±0.081.36±0.10 
 Telephone group1.51±0.081.47±0.10 

Program Evaluation

The program evaluation questionnaire was completed by 169 women, including 72 women in each intervention group and 23 women who specified their group clearly. Comparisons between groups only included women in a known treatment condition. Table 5 summarizes women's evaluations of the SPIRIT program for the entire sample. The only significant difference between groups was that peer counseled women were significantly more likely to rate the workbook as easy to understand (chi-square statistic = 6.69; P = .0352). Ninety-six percent of peer counseled women versus 83% of telephone counseled women rated the booklet as very easy to understand.

Table 5. Evaluations of the Sisters Peer Counseling in Reproductive Issues After Treatment (SPIRIT) Program at Post-Treatment Assessment
Evaluation QuestionPercentage of Total Sample
Ease of understanding SPIRIT workbook 
 Very easy83
 Somewhat easy10
 A little to very difficult7
Personal usefulness of the SPIRIT workbook 
 Very useful to me61
 Somewhat useful to me29
 A little useful/not useful10
Efficacy of workbook in covering special concerns of African-American breast cancer survivors 
  Very good job66
  Fairly good job24
  Could have been better10
Counselor's knowledge of the facts in the SPIRIT program 
 Knew facts very well78
 Knew facts reasonably well6
 Lacked knowledge16
Counselor's skills in being a good listener, communicating well, and making participant feel respected and valued 
  Very skillful79
  Somewhat skillful5
  Could have been more skillful/poor skills16
Personal utility of overall SPIRIT program 
 Very useful to me66
 Somewhat useful to me22
 A little useful/not useful to me12
Sharing information from SPIRIT with others 
 Told several individuals44
 Told 1 or 2 individuals34
 Did not discuss with anyone22

In the peer counseled group, 35% of women met with their counselor at home. The rest met in other community or medical settings. The meeting place was rated very convenient by 96% of women. Similarly, 97% rated their counselor as easy to contact and usually on time. Only 4% of women in the peer counseled group would have liked more sessions. Seventy-seven percent of women rated 3 sessions as “about right,” and 19% would have preferred fewer sessions.

In the telephone counseled group, only 22% of women called their counselor during the 6-week intervention period. Ninety-eight percent of women who attempted to call their counselor said she was easily available and responded promptly to messages. The 30 minutes of telephone time allowed was rated as about right by 53% of respondents. Thirty-one percent of women said it was more time than they needed, but 16% would have preferred more time.

Influence of Counselor Investment in the SPIRIT Study

Although very few counselors received negative ratings on skill, knowledge, or accessibility, they varied greatly in the number of participants they recruited. Of 27 counselors, 15 recruited 1 to 5 women (including peer counseled and telephone counseled women), 6 recruited 6 to 20 women, and 6 recruited >20 women (range, 22-47 women). To determine whether counselor motivation affected outcomes, scores on the FSFI, BSI-18, and knowledge test were compared across time for 31 participants who were assigned to counselors who recruited ≤5 women versus the other 257 women in the study and for 109 women who were assigned to counselors who recruited ≤20 participants and the other 179 participants. No significant differences were observed between these groups.

Influence of Use of Telephone Time

We compared outcomes (FSFI total score, BSI-18 GSI, or knowledge test scores) for women in the telephone counseled group who initiated ≥1 call to their counselor (n = 33) with those who had no contact (n = 115). The mean total number of minutes on the telephone with the counselor was 28 ± 17 minutes. No significant differences were observed at baseline or across time.

DISCUSSION

As was observed in the pilot study, participants benefited from the SPIRIT program. Women gained significantly in knowledge about breast cancer and reproductive health and reported significant decreases in hot flashes. Sexually active women reported improved sexual function through 6-month follow-up, although the advantage was lost at 1 year. Not surprisingly, given the greater difficulty in supervising a national group of counselors and longer follow-up in the national study (12 months vs 3 months), the effect sizes were somewhat smaller than those in the pilot (the value of Cohen d from baseline to final assessment in the pilot study vs the current study: emotional distress, 0.34 vs 0.14; knowledge, 0.63 vs 0.56; hot flashes, 0.22 vs 0.10). Improvements in outcomes remained significant because of the much larger sample size. Two-thirds of the women in the national study rated the SPIRIT program as very useful compared with 81% in the pilot study, and 78% shared information from the program with others in their lives. Approximately 6% to 12% of women sought new medical care for gynecologic screening, menopause symptoms, or sexual problems.

Although the national SPIRIT program was modestly successful, women in the telephone counseling condition gained as much as those in the peer counseling group, suggesting that the workbook accounted for most of the benefit. The program was rated as very useful by 68% of peer counseled women and 61% of telephone counseled women. Outcomes were no better in the 22% of women in the telephone condition who actually contacted their counselor nor in women who were seen by more experienced and motivated peer counselors. The lack of an incremental benefit of full peer counseling surprised us, particularly because our counselors reported discussions of painful sexual and fertility issues not typically disclosed in support groups. Women who received peer counseling did have a drop in depression scores after the intervention, whereas depression actually increased for women in the telephone condition, but mean scores remained within normal limits for both groups and were virtually identical by 12-month follow-up. Peer counseled women also were more likely to find the workbook easy to understand. Unfortunately, these small advantages cannot justify the time and expense of training and supervising peer counselors.

The SPIRIT program followed the important principles of working with a trusted community organization32 and developing culturally sensitive materials.33 Despite efforts to recruit underserved women, most participants were well educated and had incomes above the poverty level. The high proportion of unmarried participants was consistent with national rates for African American women.34 More affluent and educated women had better knowledge about breast cancer and reproductive health at baseline. Although sexual function and satisfaction generally were poor, women who were married and had better knowledge about reproductive health had better baseline scores. Among women who had a committed partner, both relationship satisfaction and strong spirituality contributed to better FSFI scores. The older age range of our sample may have limited our power to detect improvements in distress about infertility.

Limitations of this study include the attrition rate. Despite reminders and financial compensation, only 72% of women completed the assessment after treatment, and 62% completed the assessment at 1 year. It is possible that results are biased in a positive direction, because women who were dissatisfied with the program may have been more likely to drop out. We also did not target women at high distress for reproductive symptoms, and, emotionally, our sample generally was well adjusted. Only a few women were grieving about cancer-related infertility, although most were sexually dysfunctional. The loss at 1-year follow-up of the gains in sexual function observed at 6 months may have been related to the brief nature of the intervention and the lack of a mechanism for relapse prevention. We do not know which components of the program were responsible for the more enduring improvement in hot flashes, but 12% of women did visit a physician for menopausal symptoms during the year of the study.

In fact, this intervention may be more powerful if targeted to premenopausal African American women diagnosed with cancer. They are likely to have greater distress about sexual function and infertility4, 6, 7 and to feel very isolated.35 The SPIRIT program also may have more impact if administered soon after diagnosis, with periodic telephone or internet-based booster sessions. In the future, we hope to test these modifications to optimize the effects of the program on quality of life.

FUNDING SOURCES

This project was supported by grant RO1 CA102097 (Schover, principal investigator) from the National Cancer Institute. Support provided by the Patient-Reported Outcomes, Survey, and Population Research (PROSPR) Shared Resource. NCI funded #CA 16672.

CONFLICT OF INTEREST DISCLOSURES

The authors made no financial disclosures.

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